Feasibility of Internet Group CBT-I for Gyn Oncology Patients

NCT06060158 | Completed

• 1 other identifier: 1636910
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting. Secondary objectives:

1. 1.To compare insomnia symptoms before and after intervention.
2. 2.To evaluate any changes in quality of life symptoms while undergoing the intervention.
3. 3.To evaluate the duration of symptoms improvement after the intervention is complete.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• Attendance

  Main feasibility metric, recorded as number of sessions successfully attended. Participants would need to attend at least 4 sessions of the CBT-I sessions. Therefore, attendance among all participants must be 67% or greater to be considered feasible. A session must be attended for at least 50% of the time or will be counted as missed.

  6 weeks

• Acceptability

  A three-question survey at the end of each session. Question 1 is yes/no, questions 2 and 3 are write in. At the end of the program, a longer acceptability survey will be conducted. If a participant's response to question 1 indicates acceptability for a given session, that session will be deemed 'acceptable'. If 50% or more of participants rated the session as acceptable, then that session will be rated as acceptable.

  24 weeks

Secondary Outcomes (3)

• Insomnia symptoms

  24 weeks

• Changes in quality of life symptoms

  24 weeks

• Sleep Quality

  24 weeks

Study Arms (1)

CBT-I online group

EXPERIMENTAL

Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program. At the end of each weekly session, participants will complete a survey reviewing the acceptability of undergoing insomnia treatment in an internet-based small-group setting.

Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

6 sessions

CBT-I online group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking women greater than 18 years old who present to UC Davis Comprehensive Cancer Center for treatment or surveillance of gynecologic cancer
• Must have access to internet
• Be able to connect via secure web-based platform
• Be able to complete online questionnaires
• Moderate or severe insomnia
• Have access to a mobile device or computer

You may not qualify if:

• Participants without ability to connect with both audio and visual through secure web-based platform
• Participant is currently taking sleep medication prescribed by their provider for sleep disturbance or insomnia - Patients taking over the counter medications or supplements are eligible
• Participants with remote history of insomnia, but not currently having symptoms of insomnia
• Have other reasons for poor sleep

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hui Chen, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot feasibility study looking at delivering small group therapy online.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: September 29, 2023
• Study Start: February 26, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)